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FDA Warning Letter Explorer
Biologics · Oct 1, 2024

Pinnacle Transplant Technologies, LLC

2 extracted findings

FDA source excerpt, selected passage

Failure to establish laboratory controls that include scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity [21 CFR 211.160(b)].** For example, your finished product testing is limited to sterility testing and endotoxin testing as measurements of product attributes, and such testing does not demonstrate, for example, the identity and/or strength of your products.

Findings and supporting evidence

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

Findings extracted from the letter

Selected FDA passages, not the complete letter.

01
Failure to establish laboratory controls that include scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity [21 CFR 211.160(b)].** For example, your finished product testing is limited to sterility testing and endotoxin testing as measurements of product attributes, and such testing does not demonstrate, for example, the identity and/or strength of your products.
02
Failure to establish an adequate system for cleaning and disinfecting the room to produce aseptic conditions [21 CFR 211.42(c)(10)(v)].** Your cleaning validation is inadequate. For example, at the time of the inspection, you failed to validate the efficacy of the disinfectants used to clean and disinfect your cleanroom.

Sections and clauses cited

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

21 CFR 1271.10(a)21 CFR 1271.3(d)21 CFR 1271.1521 CFR 1271.10(a)(2)21 CFR 127121 CFR 1271.3(c)21 CFR 211.113(b)21 CFR 211.160(b)21 CFR 211.19221 CFR 211.42(c)(10)(iv)21 CFR 211.42(c)(10)(v)21 CFR 211.67(a)21 CFR 1271.10(a)(1)21 CFR 1271.10(a)(3)21 CFR 31221 CFR 210

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

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