PharmaGend Global Medical Services Pte. Ltd.
Form 483 issued February 1, 2019 · Singapore, Singapore
- Inspection
- Jan 28 – Feb 1, 2019
- Investigator
- Anastasia M. Shields
- Observations
- 2
- Pages
- 2
- FEI number
- 3012423830
In short: On February 1, 2019, FDA issued a Form 483 with 2 observations to PharmaGend Global Medical Services Pte. Ltd. in Singapore, Singapore (FEI 3012423830) after an inspection that ran Jan 28 – Feb 1, 2019. The investigator was Anastasia M. Shields. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.110 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which monitor the output of those manufacturing processes that may be…
- 02
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmPharmaGend Global Medical Services Pte. Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PharmaGend Global Medical Services Pte. Ltd.?
FDA listed 2 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected PharmaGend Global Medical Services Pte. Ltd.?
Anastasia M. Shields is named on this Form 483, for the inspection of Jan 28 – Feb 1, 2019. Each investigator has a profile showing what they cite most.
When was PharmaGend Global Medical Services Pte. Ltd. inspected by FDA?
The inspection ran Jan 28 – Feb 1, 2019, and the Form 483 is dated February 1, 2019.
How do I get the full Form 483 for PharmaGend Global Medical Services Pte. 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.