Bass & Boney, Inc.
3708 Sweeten Creek Rd.
Chapel Hill, NC 27514
Dear Mr. Bass:
On 3/31/99, Investigator Joe A. Odom of the Food and Drug Administration (PDA) conducted an inspection of your facility. This inspection was conducted to evaluate your firm's compliance with Current Good Manufacturing Practice (CGMP) regulations and to complete other assignments.
No significant deficiencies from CGMP were observed during this inspection.
Based on this finding, the Atlanta District may recommend approval of pending pre-market applications, drug applications and supplements, or export certificates for your product(s).
This information is available to Federal agencies considering the award of contracts. There may be other products and operations of your firm for which the conclusions of this inspection are not applicable. The Agency may separately inspect your firm's facilities to determine compliance with CGMP regulations or to obtain other information.
We are enclosing a copy of the establishment inspection report (EIR). This report is being provided to you for information purposes. This new procedure is applicable to EIRs for inspections conducted on or after April l, 1997. For those inspections completed prior to the above date, a copy of the EIR may still be made available through the Freedom of Information Act (FOIA).
The Agency is working to make its regulatory process and activities more transparent to the regulated industry. Releasing this EIR to you is part of this effort. The copy being provided to you comprises the narrative portion of the report. This copy may also reflect redactions made by the Agency in accordance with the FOIA and Title 21, Code of Federal Regulations. part 20. This, however, does not preclude you from requesting and possibly obtaining any additional information under FOIA.
If there are any questions about the released information, feel free to contact Philip S. Campbell, Compliance Officer, at (404) 253-1163 or write to the address noted in the letterhead.
Ballard H. Graham, Director Atlanta District