Aspen SA Sterile Operations PTY Ltd.
Form 483 issued December 4, 2018 · Korsten, South Africa
- Inspection
- Nov 26 – Dec 4, 2018
- Investigators
- Cheryl Clausen· Michael R. Shanks
- Observations
- 10
- Pages
- 13
- FEI number
- 3007490529
In short: On December 4, 2018, FDA issued a Form 483 with 10 observations to Aspen SA Sterile Operations PTY Ltd. in Korsten, EASTERN CAPE (FEI 3007490529) after an inspection that ran Nov 26 – Dec 4, 2018. The investigators were Cheryl Clausen and Michael R. Shanks. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 6 of 10 observations.
Most cited: 21 CFR 211.22 (3×) · 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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
EMPLOYEES) SONATURE pareissueo Africa Control procedures are not established which validate the performance of those manufacturing…
- 03
The quality control unit lacks authority to review production records to assure that no errors have…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Cheryl Clausen
18 documents · 2016–2020
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmAspen SA Sterile Operations PTY Ltd. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aspen SA Sterile Operations PTY Ltd.?
FDA listed 10 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Aspen SA Sterile Operations PTY Ltd.?
Cheryl Clausen and Michael R. Shanks are named on this Form 483, for the inspection of Nov 26 – Dec 4, 2018. Each investigator has a profile showing what they cite most.
When was Aspen SA Sterile Operations PTY Ltd. inspected by FDA?
The inspection ran Nov 26 – Dec 4, 2018, and the Form 483 is dated December 4, 2018.
How do I get the full Form 483 for Aspen SA Sterile Operations PTY 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.