Sunny Pharmtech Inc.
Form 483 issued April 15, 2022 · Taoyuan City, Taiwan
- Investigator
- Bryan L. McGuckin
- Observations
- 4
- Pages
- 4
- FEI number
- 3013166187
In short: On April 15, 2022, FDA issued a Form 483 with 4 observations to Sunny Pharmtech Inc. in Taoyuan City, Taiwan (FEI 3013166187). The investigator was Bryan L. McGuckin. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 4 of 4 observations.
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 objectionable microorganisms in drug products not required to be…
- 02
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
- 03
Batch production and control records do not include the identity of individual major lines used for…
- 04
Records are not kept for…
This inspection in context
Bryan L. McGuckin
30 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
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 facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Sunny Pharmtech Inc.?
Bryan L. McGuckin is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Sunny Pharmtech Inc. inspected by FDA?
This Form 483 is dated April 15, 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.