1Laboratory and QC controls
(b) (4) Laboratory records do not include complete records of any testing and standardization oflaboratory reference standards and reagents.
Inspection Record
Johnson and Johnson (McNeil) — FDA 483 Findings
Inspectors Anita R. MichaelThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Written records ofinvestigations into unexplained discrepancies do not always include the conclusions and follow-up.
3Equipment and facility
Written procedures are not followed for the cleaning and maintenance ofequipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
4Equipment and facility
(b) (4) Routine inspection ofmecbanical and electronic equipment is not performed according to a written program designed to assure proper performance.
5Complaint and recall handling
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
6Contamination control
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not.
7Other quality system
Samples taken of drug products for determination ofconformance to written specifications are not properly identified. Specifically, EMPLOVEE(S) SIGNATUR!; OATElssuao Anita R.
8Other quality system
Records associated with drug product production and control and within the retention period for such records, were not made readily available for authorized inspection.
9Equipment and facility
(b) (4) Written procedures for cleaning and maintenance fail to include description in sufficient detail ofmethods, equipment and materials used, description in sufficient detail ofthe methods ofdisassembling and reassembling equipment as necessary to assure proper cleaning and maintenance, and parameters relevant to the operation.
10Laboratory and QC controls
Laboratory controls do not include the establishment ofscientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards ofidentity, strength, quality and purity.
11Deviation, CAPA, and investigation
Deviations from written test procedures are not justified.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
