Signature Formulations LLC
11 extracted findings
FDA source excerpt, selected passage
FDA analysis showed all **(b)(4)** lots had contamination with at least **(b)(4)** of the following **(b)(4)**.
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
FDA analysis showed all **(b)(4)** lots had contamination with at least **(b)(4)** of the following **(b)(4)**.
Source passage selected by the model
02
The results of the FDA laboratory testing of **(b)(4)** drug product lots distributed in the U.S. market demonstrate that these drug products manufactured at your facility are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B) because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to Current Good Manufacturing Practices (CGMP).
Source passage selected by the model
03
Furthermore, based on information from the previous inspection these drug products are also adulterated under section 501(a)(2)(A) of the FD&C Act, 21 U.S.C. 351(a)(2)(A) in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
Source passage selected by the model
04
After FDA’s inspection of your facility documented the use of shared equipment for the production of **(b)(4)** drug products and **(b)(4)**, FDA procured samples of your **(b)(4)** drug products. Analytical testing confirmed the presence of undeclared **(b)(4)** in your **(b)(4)** drug products intended for **(b)(4)** as well as **(b)(4)**.
Source passage selected by the model
05
**(b)(4)** was detected above the limit of quantitation (LOQ) of **(b)(4)** ng/mL in all lots tested.
Source passage selected by the model
06
It is unacceptable that you have had repeated instances of **(b)(4)** contamination with your **(b)(4)** drug products.
Source passage selected by the model
07
You manufactured your **(b)(4)** products in the same manufacturing environment using shared equipment. **(b)(4)** residues remaining on shared surfaces and equipment following **(b)(4)** product manufacturing will not be adequately removed under standard cleaning conditions.
Source passage selected by the model
08
The confirmed findings across all sampled lots indicate a systemic failure that cannot be resolved through retrospective testing.
Source passage selected by the model
09
Your firm has not established appropriate design and control procedures to prevent hazardous cross contamination between your drug products.
Source passage selected by the model
10
The use of shared areas and equipment in conjunction with FDA confirmed contamination in your drug products demonstrates your products were manufactured under insanitary conditions and are adulterated under Section 501(a)(2)(A) of the FD&C Act.
Source passage selected by the model
11
we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities.
Source passage selected by the model