Winder Laboratories, LLC

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 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 of purity of the drug product beyond the official or other established requirements and you failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(a) and (b))).

Passage 2

You failed to adequately maintain your equipment. For example, the metal detection equipment MFG-1276 was found to be nonfunctioning during the inspection. Your preventive maintenance procedures were also inadequate, focusing only on the metal detector’s physical appearance rather than its operational functionality.

Passage 3

Your firm failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair (21 CFR 211.58).

Passage 4

You failed to adequately maintain your facility in a good state of repair. Specifically, we observed the following deficiencies during the inspection:

Passage 5

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.