Sunny Pharmtech Inc.
Form 483 issued September 29, 2022 · Taoyuan City, Taiwan
- Inspection
- Sep 21 – Sep 29, 2022
- Investigator
- Wayne D. McGrath
- Observations
- 4
- Pages
- 6
- FEI number
- 3013166187
In short: On September 29, 2022, FDA issued a Form 483 with 4 observations to Sunny Pharmtech Inc. in Taoyuan City, Taiwan (FEI 3013166187) after an inspection that ran Sep 21 – Sep 29, 2022. The investigator was Wayne D. McGrath. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 4 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (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 not…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Wayne D. McGrath
33 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmSunny Pharmtech Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sunny Pharmtech Inc.?
FDA listed 4 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Sunny Pharmtech Inc.?
Wayne D. McGrath is named on this Form 483, for the inspection of Sep 21 – Sep 29, 2022. Each investigator has a profile showing what they cite most.
When was Sunny Pharmtech Inc. inspected by FDA?
The inspection ran Sep 21 – Sep 29, 2022, and the Form 483 is dated September 29, 2022.
How do I get the full Form 483 for Sunny Pharmtech Inc.?
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.