1Equipment and facility
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Inspection Record
H & P Industries, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
above, which also addresses the Observation and summarizes our plan to determine the best means of providing additional physical barriers surrounding product/material-hold areas to further assure segregation of these materials.
3Laboratory and QC controls
The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established and documented.
4Labeling and packaging
Strict control is not maintained over labeling issued for use in drug product labeling operations.
5Equipment and facility
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used and description in sufficient detail of the methods ofdisassembling equipment as necessary to assure proper cleaning and maintenance.
6Quality unit oversight
the Triad Group Quality Unit was restructured on July 20.
7Material and supplier control
Reports of anaJysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
8Deviation, CAPA, and investigation
Deviations from written specifications are not justified.
9Other quality system
Drug products failing to meet established specifications are not re.iected Hemorrhoidal Suppository with Phenylephrine has a phenylephrine specification of redacted text multiple batches of this product were released outside of the specification range as follows: [table of81ots and test results].
10Equipment and facility
All major equipment used during production ofa batch ofdrug product is not properly identified at all times to indicate contents.
11Process validation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
12Other quality system
The number ofcontainers to be sampled is not based upon appropriate criteria.
13Computer system validation
Records of inspections of automatic, mechanical or electronic equipment, including computers or related systems, are not the infant and Adult Glycerin Suppository Molding Press Machine and Scale Automatic Weighing Machine (used for packaging the Glycerin Suppositories) have no records of qualification.
14Contamination control
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.
15Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not ofappropriate design for its intended use and cleaning and maintenance.
16Other quality system
The use of instruments not meeting established specifications was observed.
17Equipment and facility
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug prodUCl.
18Other quality system
Procedures describing the warehousing of drug products are not followed.
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.
