Sunday 25 June 2017

Inspections (483s and Warning Letters)

Top 10 Device Observations in 2011 (Citations made in Form 483s)

January 2, 2012 | No comments

The FDA increased the number of inspections in 2011 to a record level. This resulted in a new level of […]

Read more »

FDA issues Warning Letters for Misleading Advertising of Lap-Band

December 13, 2011 | No comments

The FDA issued warning letters for misleading Lap-Band advertising which the Agency states lacks information on the risks of gastric […]

Read more »

Baby Products with SIDS Prevention Claims

October 17, 2011 | No comments

Companies can inadvertenly fall under the FDA’s authority by how they market themselves. Medical devices include any claim to “cure, treat, […]

Read more »

Responding to 483s – Avoiding a Warning Letter

September 22, 2011 | No comments

It may be suprising when the FDA shows up to inspect your facility. It’s important tow work with the FDA […]

Read more »

FDA Inspection: Photographs During an Inspection

September 19, 2011 | No comments

The FDA asserts in its inspection manual its right to photograph in your plant. Although the inspection manual provides authority to agents, […]

Read more »

Powered by WordPress. Genius Design by MCS.