USFDA issued warning letter to Novacyl Wuxi Pharmaceutical Co., Ltd., an API & FinishedProduct manufacturer in China and let us assess our existing controls againstthese cGMP deviations/ violations.

Summary of cGMP Violations:

API: CGMP DEVIATION

1.    Failure to managelaboratory systems with sufficient controls to ensure conformance toestablished specifications and prevent omission of data.

Our inspection revealed seriousdeficiencies related to your documentation practices, including missing rawdata. It is a basic responsibility of your quality unit to ensure thatyour firm retains the supporting raw data that demonstrates your APIs meetspecifications that they are purported to possess. 

Other significant deficiencies noted inyour laboratory system include:

a)    Failure to have awritten procedure for manual integration despite its prevalence. 

b)    Failure to useseparate passwords for each analyst's access to the laboratory systems. 

c)    Use of uncontrolledworksheets for raw analytical data in your laboratory. 

d)    Presence of manyuncontrolled chromatograms, spreadsheets and notes of unknown origin found in adrawer

FINISHED PRODUCT: CGMP VIOLATIONS

2.    Your firm did notproperly document or investigate out-of-specifications (OOS) and otherdiscrepancies (21 CFR 211.192).

For example, the inspection documented thatOOS Investigation #1203, related to the presence of metal particles in (b)(4),failed to determine the root cause of the contamination or explain why the (b)(4)step was unable to prevent the contamination.   

3.    Your firm failed toestablish laboratory controls that include scientifically sound and appropriatespecifications, standards, sampling plans, and test procedures designed toassure that components, drug product containers, closures, in-process materials,labeling, and drug products conform to appropriate standards of identity,strength, quality, and purity (21 CFR 211.160(b)); and,

4.    Your firm did notrecord all CGMP activities at the time these were performed. The lack ofcontemporaneous documentation of CGMP activities increases the likelihood ofrecording erroneous data (21 CFR 211.188). 

Refer: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm427976.htm