BotableBook a call
FDA Warning Letter Explorer
FDA warning letter · Drugs

Allay Pharmaceuticals, LLC

Issued · Posted by FDA

FDA published a close-out letter on Jul 25, 2022. The passages below are from the original warning letter.

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 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 (21 CFR 211.100(a)).

Passage 2

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Passage 3

Your firm failed to perform a thorough investigation after being informed that FDA testing found OOS assay results for one lot of **(b)(4)** tablets.

Passage 4

Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

Citations in the original letter

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

  • 21 CFR 210
  • 21 CFR 211.100(a)
  • 21 CFR 211.192
  • 21 CFR 211.166(a)
  • 21 CFR 211.22
  • 21 CFR 600.3(h)(6)