Frenda Corporation

Selected passages from the FDA letter

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

Passage 1

Your firm failed to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.42(c)).

Passage 2

Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).

Passage 3

Your firm failed to establish adequate 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, and to follow all of your written production and process control procedures (21 CFR 211.100(a) and 211.100(b)).

Passage 4

You failed to adequately design, validate, and control your water system to ensure that it was suitable for producing water used in the formulation of your drug products. For example, you lacked water system validation, chemical and microbiological limits for component water, and routine monitoring for chemical and microbiological quality. Inadequate control and monitoring of your water system pose a potential risk for the presence of objectionable microbiological contamination in your drug products.

Passage 5

Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. 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 211.84(d)(2)).

Passage 6

You failed to conduct an identity test on each shipment of each lot of components used in the production of your drug products, including the active ingredient (i.e., isopropyl alcohol). Additionally, you relied on the certificates of analysis (COA) from your suppliers and failed to establish the reliability of each of your suppliers’ COA for component specifications and characteristics.

Passage 7

You failed to determine whether each component conformed with all appropriate written specifications for identity, purity, strength, and quality before using them.

Passage 8

Your firm failed to establish an adequate Quality Unit (QU) with the responsibilities and authority to oversee the manufacture of your drug products. For example, you failed to ensure:

Passage 9

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.