Re-Gen Active Lab, Inc.: FDA Warning Letter (May 27, 2022)

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1
Failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of the aseptic process [21 CFR 211.113(b)].** For example:

Passage 2
Failure to establish and follow written procedures for cleaning and maintenance of equipment used in the manufacture, processing, packing, or holding of a drug product [21 CFR 211.67(b)].

Passage 3
Failure to establish written procedures describing in sufficient detail the cleaning methods, equipment, and materials to be used in cleaning the buildings and facilities [21 CFR 211.56(b)].

Passage 4
Failure to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess [21 CFR 211.100(a)].** For example:

Passage 5
Failure to satisfy general biological products standards for sterility testing [21 CFR 610.12].** For example:

Passage 6
Failure to establish and follow written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval or rejection of components and drug product containers and closures [21 CFR 211.80(a)].** Specifically, your firm lacks written procedures describing in sufficient detail the criteria for approval or rejection of incoming human umbilical cord tissue, amniotic membrane, other components, and drug product containers and closures.

Passage 7
Failure to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use the results of such stability testing to determine appropriate storage conditions and expiration dates [21 CFR 211.166(a)].** Specifically, you assign a two-year expiration date to your products without supporting data.

Citations in the original letter

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

21 CFR 1271.10(a)
21 CFR 1271
21 CFR 1271.15
21 CFR 1271.3(d)
21 CFR 1271.10(a)(2)
21 CFR 1271.3(c)
21 CFR 1271.10(a)(1)
21 CFR 1271.3(f)(1)
21 CFR 210
21 CFR 211.113(b)
21 CFR 211.68(a)
21 CFR 211.67(b)
21 CFR 211.56(b)
21 CFR 211.100(a)
21 CFR 211.165(e)
21 CFR 211.80(a)
21 CFR 211.166(a)
21 CFR 211.188(b)
21 CFR 312
21 CFR 610.12