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FDA Warning Letter Explorer
Drugs · Apr 14, 2022

Froggy’s Fog LLC

7 extracted findings · 5 model-assigned issue types

FDA source excerpt, selected passage

Your firm was unable to provide adequate process validation and water system validation protocols or studies during our inspection of your facility. In addition, your batch records did not include any process parameters or in-process specifications to demonstrate control in the manufacture of your over-the-counter…

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Production & process controls21 CFR 211.100(a)

The firm failed to establish written production and process control procedures, lacking process validation and water system validation.

Supporting FDA text
Source excerpt · automated text-match check

Your firm was unable to provide adequate process validation and water system validation protocols or studies during our inspection of your facility. In addition, your batch records did not include any process parameters or in-process specifications to demonstrate control in the manufacture of your over-the-counter (OTC) hand sanitizer*1* drug products.

Laboratory controls & testing21 CFR 211.165(a) 21 CFR 211.165(b)

The firm failed to perform appropriate laboratory testing for each batch before release, including identity, strength, and microbiological testing.

Supporting FDA text
Source excerpt · automated text-match check

Your firm failed to adequately test your OTC drugs prior to release for distribution. For example, your batch records and certificates of analysis for your hand sanitizer drug products did not include microbiological testing or testing for impurities.

Laboratory controls & testing21 CFR 211.160(b)

The firm failed to establish adequate laboratory controls with validated analytical test methods.

Supporting FDA text
Source excerpt · automated text-match check

Your analytical test methods were not adequately validated, including those for the active ingredient ethanol, which is used to manufacture your alcohol-based hand sanitizers.

Components & suppliers21 CFR 211.84(d)(1)

The firm failed to conduct identity testing on each component lot and validate supplier test analyses.

Supporting FDA text
Source excerpt · automated text-match check

You have not demonstrated that you adequately test all incoming raw materials used in the manufacture of your drug products, including identity testing on each lot of incoming raw material.

Facilities & equipment21 CFR 211.67(b)

The firm failed to validate cleaning processes for non-dedicated manufacturing equipment.

Supporting FDA text
Source excerpt · automated text-match check

Your firm did not validate your cleaning processes used for cleaning non-dedicated manufacturing equipment.

Labeling, claims & marketing

The product label falsely represents the concentration of ethyl alcohol, making the product misbranded.

Supporting FDA text
Source excerpt · automated text-match check

SIMPLY 70 HAND SANITIZER GEL (70% Alcohol) is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because according to the product label, SIMPLY 70 HAND SANITIZER GEL (70% Alcohol) contains the active ingredient ethyl alcohol 70% v/v. However, FDA laboratory analyses of this product demonstrate that SIMPLY 70 HAND SANITIZER GEL (70% Alcohol) contains ethyl alcohol in an average concentration of ethanol 60% v/v.

Findings extracted from the letter

Selected FDA passages, not the complete letter.

01
Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
21 CFR 211.100(a)
02
Your firm failed to perform, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release, and for each batch of drug product required to be free of objectionable microorganisms, appropriate laboratory testing, as necessary (21 CFR 211.165(a) and 21 CFR 211.165(b)).
21 CFR 211.165(a) 21 CFR 211.165(b)
03
Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
21 CFR 211.160(b)
04
Your firm failed to conduct (b)(4) test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and (2)).
21 CFR 211.84(d)(1)
05
Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).
21 CFR 211.67(b)
06
Your firm did not validate your cleaning processes used for cleaning non-dedicated manufacturing equipment. Inadequate removal of residues from the product contact surfaces of manufacturing equipment during cleaning can contaminate drug products subsequently manufactured on non-dedicated equipment.
07
Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.

What FDA requested

Model-assisted summary. Consult the letter for complete requests and conditions.

  • Provide a detailed summary of the validation program for ensuring a state of control throughout the product lifecycle.
  • Provide a timeline for performing process performance qualification for each marketed drug product.
  • Provide a detailed program for designing, validating, maintaining, controlling and monitoring each manufacturing process.
  • Provide a procedure for water system monitoring specifying routine microbial testing of water.
  • Provide a procedure for ongoing control, maintenance, and monitoring of the water system.
  • Provide a list of chemical and microbial specifications and test methods used for each lot.
  • Provide an action plan and timelines for full chemical and microbiological testing of retain samples.
  • Provide a summary of all results from testing retain samples from each batch.

Sections and clauses cited

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 211.100(a)21 CFR 211.165(a)21 CFR 211.165(b)21 CFR 211.160(b)21 CFR 211.84(d)(1)21 CFR 211.67(b)21 CFR 201.12821 CFR 210

For background, see Current good manufacturing practice (CGMP). Explore Botable’s work in Pharmaceuticals and Quality and regulatory operations.

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