Sinopep-Allsino Biopharmaceutical Co., Ltd.
Form 483 issued April 11, 2014 · Lianyungang, China
- Inspection
- Apr 11, 2014
- Investigator
- Robert J. Martin
- Observations
- 9
- Pages
- 3
- FEI number
- 3005460102
In short: On April 11, 2014, FDA issued a Form 483 with 9 observations to Sinopep-Allsino Biopharmaceutical Co., Ltd. in Lianyungang, Jiangsu (FEI 3005460102) after an inspection that ran Apr 11, 2014. The investigator was Robert J. Martin. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.87 (retesting of approved components, drug product containers, and closures).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
during the analysis for Impurit batch ()@)) 99), by High Performance Liquid Chromatography. in the Stability…
- 02
The Quality Unit failed to review and approve the Installation and Operation…
- 03
The firm failed to adequately validate the cleaning processes (VR-CV-1003-2012-00) used…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Robert J. Martin
29 documents · 2014–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
The firmSinopep-Allsino Biopharmaceutical Co., Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sinopep-Allsino Biopharmaceutical Co., Ltd.?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.87 (retesting of approved components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Sinopep-Allsino Biopharmaceutical Co., Ltd.?
Robert J. Martin is named on this Form 483, for the inspection of Apr 11, 2014. Each investigator has a profile showing what they cite most.
When was Sinopep-Allsino Biopharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Apr 11, 2014, and the Form 483 is dated April 11, 2014.
How do I get the full Form 483 for Sinopep-Allsino Biopharmaceutical Co., Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.